跳至主要内容
临床试验/NCT03035019
NCT03035019已完成不适用

Reducing Stress in Primary Care Patients

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 593 人开始时间: 2016年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
593
试验地点
2
主要终点
Patient satisfaction/acceptability post program

研究概览

简要总结

Stress and anxiety can worsen quality of life in patients seen in primary care practices. This project is set in UPMC primary care practices (CMI) to evaluate how the availability of a virtual stress management program can help patients reduce stress and anxiety and improve their quality of life. The project will analyze the efficacy of the virtual stress management program at these practices so that it can then be utilized effectively in other medical settings where it can be offered as a part of clinical care to reduce stress and anxiety and improve the quality of life of medical patients who could benefit from a reduction in stress. This research is being piloted at these sites in the hopes of publishing results that show that it can be implemented in other practices throughout the country.

Additionally, at other UPMC CMI primary care sites, de-identified data will be collected in order to serve as a comparison.

详细描述

All patients who are receiving or seeking medical care at UPMC CMI practices are given the GAD7(anxiety) and SF-12(quality of life) as a part of their routine medical care. Since this project is occurring at the same practices where a randomized study evaluating treatments for acute back pain (IRB Protocol #015120249), patients with acute back pain will be excluded from this project.

Patient scores become part of the EMR (Epic). A best practice alert will be generated for patients in the age range of 20-65 (inclusive) and in the targeted GAD7 score range (GAD7 ≥5) to prompt the provider to recommend the stress management program (Lantern). The age range was chosen to exclude adolescents who may have different needs, and the geriatric population who is involved in other behavioral studies at these practices.

The Best Practice alert will prompt the clinic staff to gather promotional Lantern materials and pend an order in Epic for stress management registration. When the clinical staff sees the pended order and Lantern materials, clinic staff will decide if the stress management program is appropriate for the patient. The discussion will include a disclaimer that the stress management program does not offer treatment. Clinical staff and patient will also discuss whether or not the patient wishes to consent to participate in Lantern and be contacted Lantern. The clinical staff will question the patient about smartphone or tablet (specifically, iOS or Android) access/availability during the consent process. If the patient is interested, the clinician will submit the order and the patient will sign the consent to participate in the stress management program (Lantern). The use of Lantern is set up at these two CMI sites as part of this research study. It is not for normal clinical care for UPMC patients.

The order generates a paragraph about the stress management program provided to the patient as a written order. The order sends an Epic InBasket to the UPMC Enterprises project team (including the patient's MRN, name, date of birth and contact information). When each order is received, the UPMC Enterprises project team will enter the patient into the registration system, generating a unique ID for each patient.

The registration system will send out an email message to the third-party stress management program (including the unique ID, name, date of birth, and contact information) through a secure VPN connection between UPMC Enterprises and Lantern to inform them of people who have consented.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals who are receiving or seeking medical care at UPMC CMI aged 20-65 who have a GAD7 score ≥ 5 must be English speaking and capable of understanding the informed consent and providing consent or assent and having access to a Smartphone.

排除标准

  • Patients under age 20 and older than 65 will be excluded. Patients whose GAD7 score is <5 will also be excluded. Patients who do not own a smartphone or mobile device will also not be included. Since this project is occurring at the same practices where a randomized study evaluating treatments for acute back pain (IRB Protocol # 015120249), patients with acute back pain will be excluded from this project.

研究组 & 干预措施

Lantern for primary care patients

Experimental

All patients between the ages of 20-65 at specific primary care practices and score 5 or greater on the GAD7 questionnaire are offered the Lantern app to help with stress/anxiety.

干预措施: Lantern (Behavioral)

结局指标

主要结局

Patient satisfaction/acceptability post program

时间窗: 6 months after consent

A measure to determine patient satisfaction of the Lantern program

GAD7 scores (anxiety) completion.

时间窗: 12 months

GAD7 anxiety questionnaires are completed at time points throughout the study

次要结局

  • Quality of life (SF-12)(12 months)
  • medical utilization(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eva Szigethy

MD, Phd

University of Pittsburgh

研究点 (2)

Loading locations...

相似试验

Reducing Stress in Primary Care Patients | 临床试验